Résultats des tests de spécification
GMP Manufactured Product |
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Meets B.P. Chemical Specifications |
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Meets ChP Chemical Specifications |
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Meets J.P. Chemical Specifications |
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Meets U.S.P Requirements |
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Meets E.P. Chemical Specifications |
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Preserve in Tight Containers |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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USP - Assay (C6H14N402·HCl) (dried basis) |
98.5 - 101.5% |
USP - Identification |
Passes Test |
USP - Specific Rotation (A]2°AO (+) |
21.4 - 23.6° |
USP - Loss on Orying at 105 °C |
≤0.2% |
USP - Residue on Ignition |
≤0.1% |
USP - Sulfate (S04) |
≤0.03% |
USP - Related Compounds - Individual Impurities |
≤0.5% |
USP - Related Compounds - Total Impurities |
≤2.0% |
USP - Chloride (Cl) |
16.5 - 17.1% |
EP/BP - Assay (C6H14N402·HCl) (dried basis) |
98.5 - 101.0% |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification E |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Specific Rotation (A]2°AO (+) |
21.0 - 23.5° |
EP/BP-Ninhydrin-Positive Substances-Each |
≤0.2% |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤0.5% |
EP/BP - Sulfate (S04) |
≤300 ppm |
EP/BP - Ammonium (NH4) |
≤0.02% |
EP/BP - Iron (Fe) |
≤10 ppm |
EP/BP - Loss on Orying |
≤0.5% |
EP/BP - Ash (sulfated) |
≤0.1% |
JP - Assay (C6H14N402·HCl) (dried basis) |
98.5 - 101.0% |
JP - Identification |
Passes Test |
JP - 0ptical Rotation (+) |
21.5 - 23.5° |
JP - pH (1 in 10) |
4.7 - 6.2 |
JP - Clarity and Color of Solution |
Passes Test |
JP - Sulfate (S04) |
≤0.028% |
JP - Ammonium (NH4) |
≤0.02% |
JP - Arsenic (As) |
≤2 ppm |
JP - Related Substances |
Passes Test |
JP - Loss on Orying at 105 °C |
≤0.20% |
JP - Residue after Ignition |
≤0.10% |
Endotoxin Concentration, IU/mg, For Information only |
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ChP - Transmittance of solution |
≥ 98.0% |
ChP - Sulfates |
≤0.02% |
ChP - Ammonium |
≤0.02% |
ChP - Loss on drying @ 105 °C |
≤0.2% |
ChP - Residue on ignition |
≤0.1% |
ChP - Heavy metals |
≤0.001% |
ChP - Arsenic |
≤0.0001% |
ChP - Identification 1 (TLC) |
Passes Test |
ChP - Identification 2 (IR) |
Passes Test |
ChP - Chloride Content |
16.5 - 17.1% |
ChP - 0ther amino acids (TLC)(<=0.2%, one spot only) |
Passes Test |
ChP - Proteins |
Passes Test |
ChP - Iron |
≤0.001% |
ChP - Specific Rotation @ 20 °C (+) |
21.5 - 23.5 |
ChP - Phosphates |
≤0.02% |
ChP - Assay (dried basis) |
98.5 - 101.0% |